The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Hitachi Cb Mercuray Dental Cone-beam X-ray System.
Device ID | K033248 |
510k Number | K033248 |
Device Name: | HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM |
Classification | System, X-ray, Extraoral Source, Digital |
Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
Contact | Doug Thistlethwaite |
Correspondent | Donald James Sherratt INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | MUH |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-10-07 |
Decision Date | 2003-10-20 |
Summary: | summary |